FDA recall D-1350-2014

Sandoz, Inc · Class II · drug

Product

Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20.

Reason for recall

Presence of Foreign Substance: Presence of stainless steel particles.

Distribution

Nationwide including Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2014-05-22
Report date: 2014-06-04
Termination date: 2015-02-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1350-2014